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Before long, serious problems will arise and the employees of the company will, without doubt, feel immense amounts of frustration with the lack of organization.Every company will need some kind of an SOP, and - ironically - they need to have a set of standards in place before the SOP can be implemented.There is no intent to move to using epinephrine and norepinephrine as the new ingredient names.
When your company is audited or inspected by the FDA, you will need to show a system for monitoring and controlling your SOPs.
If you don't already have one in place, start it today!
Standard Operating Procedures (SOPs) have become such a critical part of how organizations function that the International Organization of Standardization was created to ensure that companies were doing it right.
The most frequently reported deficiencies during FDA inspections are: Failure to pass an inspection will result in a warning letter from the FDA.
If you’ve already received a warning letter, developing procedures and controlling them will be critical aspects of your Corrective Action Plan.